Recall Z-0619-2019— ICU Medical Inc
Class II · Terminated
Class II FDA medical device recall by ICU Medical Inc, initiated 2018-11-08, terminated 2020-10-13. It names one FDA 510(k) clearance: K171346. Product: SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch, List Number 16373-02 Sapphire Epidural Sets are indicated for the delivery of fluids from a container to a patient's epidural space. Sets are intended for use with Sapphire Infusion Systems.. Reason: There have been reports of distal occlusion alarms during the use of SAPPHIRE Epidural Set Yellow-Striped administration sets..
- Recalling firm
- ICU Medical Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-11-08
- Terminated
- 2020-10-13
- Firm location
- LAKE FOREST, IL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch, List Number 16373-02 Sapphire Epidural Sets are indicated for the delivery of fluids from a container to a patient's epidural space. Sets are intended for use with Sapphire Infusion Systems.
Reason for recall
There have been reports of distal occlusion alarms during the use of SAPPHIRE Epidural Set Yellow-Striped administration sets.
Data sourced from openFDA. This site is unofficial and independent of the FDA.